Friday, 06 December 2019

SGD Pharma launches digital tool for compliance

19 November 2019 | News

SGD Pharma has launched an App to identify non-compliances in molded glass bottles intended for the pharmaceutical industry

Resulting from a development project between SGD Pharma Quality and Marketing departments, this new digital tool makes it possible to identify non-compliances that may be discovered during an incoming inspection or during on-line inspection at client’s side. The SGD Pharma App is a testament to our commitment to continuous improvement. It also demonstrates transparency in working with customers toward the mutual objective of safeguarding patient health. As a leader in molded glass pharmaceutical packaging for the healthcare sector, SGD Pharma makes product quality an essential part of its mission.
The SGD Pharma App aims at optimizing and harmonizing exchanges with quality controllers and technical staff by making it easier to identify non-compliances that could be present in molded glass bottles intended for pharmaceutical use.

Available for free from the Apple Store and the Play Store, it only takes a few clicks for users to create their account and have unlimited access to a 2D visual compilation of the most frequently encountered forms of non-compliance. Users can refine their searches by administration method (parenteral, oral or nasal), by location or non-compliance types corresponding to various effects on the patients or on filling lines (critical, major or cosmetic).


Once a non-compliance has been identified, the user then accesses a dedicated page including a visual, a definition, the type of non-compliance and its associated acceptable quality level (AQL) in conjunction with the international standard ISO 2859-1. As an added benefit, the SGD Pharma standards are then cross-referenced with the two quality benchmarks recognized and accepted by the Pharmaceutical industry: technical report 43 from the Parenteral Drug Association (PDA) and the list of molded glass container non-compliances from Edito-Cantor-Verlag (ECV).

According to Quentin Ritter, Quality Project Manager at SGD Pharma: “This application project was initiated in response to our customers’ increasing demand for glass non-conformities training. It is crucial for them to be able to identify and recognize non-conformities quickly in order to improve inspection processes and make the right decision.” The application is intuitive and comprehensive and offers reliable practical information. "The mission of SGD Pharma,” adds Emmanuel Lepitre, Head of Development and Quality, “is to improve safety for the end user. SGD Pharma App answers to the growing zero tolerance trend, including cosmetic quality, by hospital staff. With this application, open to all professionals in the industry, designed upstream with its customers in mind, SGD Pharma aims to support the Pharmaceutical Industry to protect patient health."

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